Challenges faced by the HIV testing system in low- and middle-income countries

Introduction: Determining the HIV status of some individuals remains challenging due to multidimensional factors such as flaws in diagnostic systems, technological challenges, and viral diversity. This report pinpoints challenges faced by the HIV testing system in Cameroon. Case presentation: A 53-year-old male received a positive HIV result by a rapid testing algorithm in July 2016. Not convinced of his HIV status, he requested additional tests. In February 2017, he received a positive result using ImmunoComb® II HIV 1 & 2 BiSpot and Roche cobas electrochemiluminescence assays. A sample sent to France in April 2017 was positive on the Bio-Rad GenScreen™ HIV 1/2, but serotyping was indeterminate, and viral load was < 20 copies/mL. The Roche electrochemiluminescence immunoassay and INNO-LIA HIV I/II Score were negative for samples collected in 2018. A sample collected in July 2019 and tested with VIDAS® HIV Duo Ultra enzyme-linked fluorescent assay and Geenius™ HIV 1/2 Confirmatory Assay was positive, but negative with Western blot; CD4 count was 1380 cells/mm3 and HIV proviral DNA tested in France was 'target-not-detected'. Some rapid tests were still positive in 2020 and 2021. Serotyping remained indeterminate, and viral load was 'target-not-detected'. There were no self-reported exposure to HIV risk factors, and his wife was HIV-seronegative.Management and outcome: Given that the patient remained asymptomatic with no evidence of viral replication, no antiretroviral therapy was initiated. Conclusion: This case highlights the struggles faced by some individuals in confirming their HIV status and the need to update existing technologies and develop an algorithm for managing exceptional cases.

Stigma kills

@#Stigma due to an HIV diagnosis is a well-known phenomenon and is a major barrier to accessing care.1 Over the last forty years, HIV has been transformed from a fatal disease to a manageable one, thanks to the remarkable success of antiretroviral (ARV) medication.2 When people living with HIV (PLHIV) start ARV treatment early, their life expectancy is almost completely restored. Moreover, a suppressed viral load means that PLHIV are no longer able to infect other people.3 They can have children naturally without risk to their seronegative partner or their child. PLHIV nowadays are more likely to die with HIV, not of HIV. While a cure remains elusive, the successful global rollout of ARVs means that there is no good reason for a PLHIV to die of AIDS and its complications due to lack of access to proper treatment. The Philippine AIDS Law Republic Act 8504 and its successor, Republic Act 11116 explicitly states that the State should “ensure access to HIV and AIDS-related services by eliminating the climate of stigma and discrimination that surrounds the country’s HIV and AIDS situation, and the people directly and indirectly affected by it.” Unfortunately, despite this admonition, stigma remains a significant cause of delayed HIV testing and of not seeking treatment in our country. In this issue of the journal, Dr. De Los Santos and her colleagues examine the effect of healthcare facility stigma on PLHIV accessing care in the Philippines.4 They report that 81% of their Filipino PLHIV respondents experienced stigma, which is an unacceptably high number. They identify which facilities are more likely to be correlated with stigma and make suggestions on how to address this problem. This study is very timely and comes at a time when the Department of Health is shifting first line antiretrovirals to dolutegravir-based regimens.5 Dolutegravir-based treatment is associated with fewer side effects than efavirenz-based regimens and is much more durable against resistance.6 With an HIV transmitted-drug resistance rate of 11.7%, it is imperative that PLHIV are started on more durable regimens which they are less likely to discontinue.7 Properly addressing stigma means that more people will access care. Better regimens will ensure that people stay in care. This will go a long way towards minimizing the impact of HIV and AIDS on Filipino PLHIV. Stigma among PLHIV is a complicated subject matter. Aside from the stigma associated with diagnosis, there is also stigma associated with the mode of acquisition of the disease. The most-at-risk populations are highly stigmatized. Men who have sex with men, people who inject drugs, and female sex workers experience additional stigma on top of the stigma from an HIV diagnosis.8 Aside from societal stigma, PLHIV are also prone to self-stigma.9 This phenomenon occurs when PLHIV believe they no longer deserve to live since they contracted the disease from deviant or sinful behavior. High rates of depression are found among these self-stigma sufferers. This significantly impacts the entire HIV healthcare cascade, starting from early diagnosis, to accessing treatment, and staying in care. The finding that Public Rural Health Units are the most stigmatizing healthcare facilities is very concerning since these are usually the only facilities available to PLHIV in far-flung areas. This needs to be addressed with better sensitivity training as well as concrete guidelines on avoiding stigma. It is very troubling that facilities that are supposed to cater to vulnerable populations inadvertently make it difficult for them to access care.10 Unfortunately, even facilities in urban areas are not immune to discrimination and stigmatizing behavior. I recall the experience of one of my early PLHIV patients who developed and eventually succumbed to a disseminated fungal infection.11 He told me that he had tried getting tested several years earlier but he had a traumatic experience in the government health facility that he accessed. He made a wrong turn and entered a different clinic in that hospital and when he asked for an HIV test, people recoiled from him in horror. Because of that terrible experience, he put off getting his HIV test for years until he started developing the fungal infection that eventually killed him. Had he been started on proper treatment earlier, he could have been saved. For me, it wasn’t just the fungus that killed him but it was the delay in diagnosis and care as a direct result of stigma. Addressing HIV-related stigma in our country entails a whole-of-society and a whole-of-nation approach. Mental health services to address self-stigma and depression should be standard of care not just among confirmed PLHIV but among the most-at-risk populations. Proactive education of all members of society, especially healthcare workers in facilities that diagnose and care for PLHIV is essential for ensuring sustained linkage to care. Ensuring that the majority of the PLHIV population are properly diagnosed, enrolled in treatment hubs, and have suppressed viral loads will ultimately lead to fewer transmissions and less AIDS-related deaths.

Repercussões do diagnóstico do Vírus da Imunodeficiência Humana e perspectivas acerca do tratamento / Repercussions of Human Immunodeficiency Virus diagnosis and perspectives on treatment / Repercusiones del diagnóstico del Virus de la Inmunodeficiencia Humana y las perspectivas a cerca del tratamiento

Objetivo: Analisar as repercussões do diagnóstico do Vírus da Imunodeficiência Humana (HIV) e as perspectivas acerca do tratamento em pessoas atendidas em um centro de testagem e aconselhamento. Métodos: Realizou-se uma pesquisa qualitativa, por meio da análise de narrativas de 28 pessoas que vivem com HIV atendidas em um centro de testagem e aconselhamento de Pinheiro, Maranhão, Brasil. Durante o período de fevereiro a junho de 2019, aplicaram-se entrevistas semiestruturadas contendo questões sociodemográficas, sobre o diagnóstico e o tratamento. Resultados: Os impactos pós-diagnóstico e as pespectivas sobre o tratamento apresentaram-se como as categorias emergentes das análises. As narrativas demonstraram as formas como o diagnóstico do HIV pode refletir na vida do indivíduo, principalmente quanto às questões social e econômica e quanto ao enfrentamento de estigmas e preconceitos relativos à infecção. A terapia antirretroviral, ainda que importante para a manutenção da saúde, pode sofrer empecilhos devido aos desafios que acometem os participantes da pesquisa. Conclusão: O afastamento de familiares e amigos, o sentimento de exclusão, a maior preocupação com a saúde e a dificuldade de obter renda representam as maiores repercussões no pós-diagnóstico. assim, o tratamento é considerado uma medida de promoção à saúde e impedimento de avanço da infecção, podendo ser afetado por diversas questões, dentre elas a financeira.

Objective: To analyze the repercussions of Human Immunodeficiency Virus (HIV) diagnosis and the perspectives on the treatment in people attending a testing and counseling center. Methods: A qualitative research was carried out using analysis of narratives of 28 people living with HIV treated at a testing and counseling center in Pinheiro, Maranhão, Brazil. From February to June 2019, semi-structured interviews were carried out using sociodemographic questions about diagnosis and treatment. Results:Post-diagnosis impact and treatment perspectives were categories that emerged from the analyses. The narratives showed the ways in which the HIV diagnosis can reflect on the individual's life, especially regarding social and economic issues and the confrontation of stigma and prejudice related to the infection. Although important for the maintenance of health, antiretroviral therapy can face obstacles due to the challenges that affect the research participants. Conclusion: Distancing from family and friends, the feeling of exclusion, the greater concern with health and the difficulty in earning an income represent the greatest repercussions after diagnosis. Thus, treatment is considered a measure to promote health and prevent the progress of infection, but it can be affected by several issues, including financial ones.

Objetivo: Analizar las repercusiones del diagnóstico del Virus de la Inmunodeficiencia Humana (VIH) y las perspectivas del tratamiento de personas asistidas en un centro de pruebas para el diagnóstico y consejería. Métodos: Se realizó una investigación cualitativa a través del análisis de narrativas de 28 personas que tienen el VIH y que son asistidas en un centro de pruebas de diagnóstico y consejería de Pinheiro, Maranhão, Brasil. Se aplicaron entrevistas semiestructuradas con preguntas sociodemográficas, el diagnóstico y el tratamiento durante el período entre febrero y junio de 2019. Resultados: Los impactos posdiagnóstico y las perspectivas sobre el tratamiento se presentaron como las categorías emergentes de los análisis. Las narrativas demostraron las formas como el diagnóstico de VIH puede influenciar en la vida del individuo, en especial sobre los aspectos social y económico y sobre el enfrentamiento de los estigmas y perjuicios de la infección. La terapia antirretroviral, aunque sea importante para la manutención de la salud, puede tener objeciones debido a los desafíos que acometen los participantes de la investigación. Conclusión: El alejamiento de los familiares y los amigos, el sentimiento de exclusión, mayor preocupación con la salud y la dificultad de una renta representan las mayores repercusiones del pos diagnóstico. De esa manera, se considera el tratamiento como una medida de promoción de la salud y barrera para el avanzo de la infección que puede ser afectado por distintos aspectos, entre ellos, el financiero.

Blood collection on filter paper for HIV antibodies detection: experience of SampaCentro Project / Colheita de sangue em papel filtro para detecção de anticorpos anti-HIV: experiência do Projeto SampaCentro

Introduction: Blood samples collected on filter paper (dried blood spot [DBS]) is an immunoassay that has been used for antibodies screening. Objective: To evaluate the strategy of DBS blood collection for detection of HIV antibodies, evaluation of Q-Preven HIV 1 + 2 - DBS kit lot, and to analyze the stability of DBS samples. Methods: Blood collection on DBS was performed according to World Health Organization (WHO) recommendations. The evaluation of the kit lot for HIV antibodies detection was performed using delta (d) values from the results of 774 DBS samples from volunteers men who have sex with men (MSM) recruited in the central region of São Paulo city, Brazil. Results: DBS blood collection was performed without complications. The positive (5.26) and negative (5.23) delta values allowed to clearly differentiate HIV antibodies reactive and non-reactive samples. We observed good performance of the kit lot and samples were stable on DBS form. Conclusion: Blood collection on DBS is feasible for the study of MSM population and is suitable for laboratory routine. The overall performance of Q Preven HIV-1 + 2 - DBS kit was satisfactory, having reached the quality levels required for the development of this study. .

Introdução: As amostras de sangue colhidas em papel filtro (DBS) têm sido utilizadas na triagem de anticorpos por meio de imunoensaios. Objetivos: Avaliar a estratégia de colheita de sangue em DBS para detecção de anticorpos contra o vírus da imunodeficiência humana (HIV), verificar o lote do kit Q-Preven HIV 1+2 - DBS e analisar a estabilidade das amostras DBS. Métodos: A colheita de sangue em DBS foi realizada conforme recomendações da Organização Mundial da Saúde (OMS). A avaliação do lote do kit para detecção de anticorpos anti-HIV foi feita por meio do valor de delta a partir dos resultados das 774 amostras DBS provenientes de voluntários homens que fazem sexo com homens (HSH) recrutados na região central da cidade de São Paulo, Brasil. Resultados: A colheita de sangue em DBS foi realizada sem intercorrências. O indicador delta positivo (5,26) e negativo (5,23) permitiu discriminar com clareza amostras anti-HIV reagentes e não reagentes. O lote do kit apresentou bom desempenho e as amostras permaneceram estáveis na forma de DBS. Conclusão: A colheita de sangue em DBS mostrou-se factível para o estudo realizado com a população HSH e foi adequada para a rotina laboratorial. O desempenho global do kit Q-Preven HIV 1+2 - DBS foi satisfatório, com a qualidade requerida para o desenvolvimento deste estudo. .

Evaluation of Calypte AWARE HIV-1/2 OMT antibody test as a screening test in an Indian setting.

Purpose: Integrated counselling and testing centres (ICTC) provide counselling and blood testing facilities for HIV diagnosis. Oral fluid tests provide an alternative for people whodo not want blood to be drawn. Also, it avoids the risk of occupational exposure. The goal of this study was to evaluate the utility of Calypte AWARE HIV-1/2 OMT antibody test as a screening test in an Indian setting. Materials and Methods: A cross-sectional study was carried out after ethics committee approval in 250 adult ICTC clients. Blood was collected and tested from these clients for HIV diagnosis as per routine policy and the results were considered as the gold standard. Also, after another written informed consent, oral fluid was collected from the clients and tested for the presence of HIV antibodies. Twenty five clients who had and 25 clients who had not completed their secondary school education (Group A and Group B, respectively) were also asked to perform and interpret the test on their own and their findings and experiences were noted. Result: The sensitivity, specificity, PPV and NPV of the oral fluid antibody test were 100%, 98.51%, 94.11% and 100%, respectively. Seventy six percent of clients preferred oral fluid testing. Group B found it difficult to perform the test as compared to Group A and this difference was statistically significant (P ≤ 0.05). Conclusion: Oral fluid testing can be used as a screening test for HIV diagnosis; however, confirmation of reactive results by blood-based tests is a must.

Evaluation of the human immunodeficiency virus type 1 and 2 antibodies detection in dried whole blood spots (dbs) samples / Pesquisa de anticorpos contra o vírus da imunodeficiência humana tipos 1 e 2 em amostras de sangue seco coletadas em papel filtro

Human Immunodeficiency Vírus Type 1 and 2 antibodies detection was performed in 457 dried whole blood spots samples (S&S 903). Q-Preven HIV 1+2 was the screening test used. The results were compared with the gold standard serum tests by ELISA (Cobas Core e Axsym HIV1/2 gO) and imunofluorescence was the definitive confirmatory test. The samples were obtained from the Hospital Nossa Senhora da Conceição in Porto Alegre, RS - Brazil, through whole blood transfer to filter paper card and sent to Caxias do Sul, RS - Brazil where the tests were performed. The dried whole blood spot stability was evaluated with two different panels. The first one was composed of five negative and five positive samples stored at room temperature, 4 ºC, -20 ºC and -70 ºC, while the second was composed of two negative and three positive samples stored at 37 ºC (humidity <50 percent). Each sample was screened every week for six weeks. These measurement results didn't show variation during the study period. The detected sensibility was 100 percent, specificity was 99.6 percent, the positive predictive value was 99.5 percent and negative predictive values were 100 percent. The results demonstrated high performance characteristics, opening a new perspective of dried whole blood spot utilization in HIV screening diagnosis.

Foram realizados 457 testes para detectar anticorpos contra o Vírus da Imunodeficiência Humana tipos 1 e 2, em amostras de sangue total seco coletadas em papel filtro (S&S 903), com o teste de triagem Q-Preven HIV 1+2, comparando-se com os resultados dos testes de triagem no soro (Cobas Core e Axsym HIV1/2 gO), sendo a imunofluorescência indireta o teste confirmatório. As amostras foram obtidas no Hospital Conceição em Porto Alegre, pela transferência de sangue total para cartão de papel filtro e encaminhadas para Caxias do Sul para a realização dos testes. Foi analisada a estabilidade da amostra em papel filtro com a utilização de dois painéis: o primeiro com cinco amostras negativas e cinco positivas armazenadas por seis semanas à temperatura ambiente, 4 ºC, -20 ºC e -70 ºC; o segundo com duas negativas e três positivas armazenadas por seis semanas com avaliações semanais a 37 ºC (umidade <50 por cento). Os resultados de todas as amostras testadas foram mantidos. A sensibilidade foi de 100 por cento, a especificidade de 99,6 por cento, o valor preditivo positivo de 99,5 por cento e o valor preditivo negativo de 100 por cento. O excelente desempenho observado na análise da utilização de sangue seco em papel filtro, abre uma nova perspectiva no diagnóstico da infecção pelo HIV.

Quality of HIV laboratory testing in Tanzania: a situation analysis

Tanzania is scaling up prevention; treatment; care and support of individuals affected with HIV. There is therefore a need for high quality and reliable HIV infection testing and AIDS staging. The objective of this study was to assess laboratories capacities of services in terms of HIV testing and quality control. A baseline survey was conducted from December 2004 to February 2005 in 12 laboratories which were conveniently selected to represent all the zones of Tanzania. The questionnaires comprised of questions on laboratory particulars; internal and external quality control for HIV testing and quality control of reagents. Source and level of customer satisfaction of HIV test kits supply was established. Of 12 laboratories; nine used rapid tests for screening and two used rapid tests for diagnosis. In the 12 laboratories; four used double ELISA and five used single ELISA and three did not use ELISA. Confirmatory tests observed were Western Blot in three laboratories; DNA PCR in two laboratories; CD4 counting in seven laboratories; and viral load in two laboratories. Although all laboratories conducted quality control (QC) of the HIV kits; only two laboratories had Standard Operating Procedures (SOPs). Internal and external quality control (EQC) was done at varied proportions with the highest frequency of 55.6(5/9) for tnternal quality control (IQC) for rapid tests and EQC for ELISA; and the lowest frequency of 14.3(1/ 7) for IQC for CD4 counting. None of the nine laboratories which conducted QC for reagents used for rapid tests and none of the five which performed IQC and EQC had SOPs. HIV kits were mainly procured by the Medical Store Department and most of laboratories were not satisfied with the delay in procurement procedures. Most of the laboratories used rapid tests only; while some used both rapid tests and ELISA method for HIV testing. In conclusion; the survey revealed inadequacy in Good Laboratory Practice and poor laboratory quality control process for HIV testing reagents; internal and external quality control